Post-market SUrveiLlance RegiStry for the Endogenex System (Endogenex PULSE Registry)

This registry is designed to collect long-term data and support ongoing post-market surveillance of real-world data for the Endogenex System.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Type2diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia

About this study

This is an observational registry that is designed to facilitate long-term patient follow-up for up to 5 years after an Endogenex procedure. It is structured to enable systematic longitudinal data collection on the safety and long-term clinical outcomes associated with the Endogenex System.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes
Have been treated with the Endogenex System
Consented to participate in the Endogenex PULSE Registry

Exclusion criteria

Unwilling or unable to attend study visits
Unwilling or unable to provide medical records to study sites

Treatment and study plan

Primary outcomes

Incidence of adverse events

Time frame: Through 5 years

Incidence of device-related and/or procedure-related adverse events

Sponsors and collaborators

Lead sponsor

Endogenex, Inc.

Industry

Registry information

Official study title

Endogenex PULSE Registry

Important dates

Study start: 2026
Primary completion: 2032
Study completion: 2032
First posted: Sep 29, 2025
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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